The trial is taking place at:
R

Rochester Clinical Research | Rochester, NY

Veeva-enabled site

A Study Assessing Rocatinlimab on Vaccine Antibody Response in Moderate-to-severe Atopic Dermatitis (AD) (ROCKET - VOYAGER) (ROCKET-VOYAGER)

Amgen logo

Amgen

Status and phase

Active, not recruiting
Phase 3

Conditions

Atopic Dermatitis
Moderate-to-severe Atopic Dermatitis

Treatments

Drug: Placebo
Drug: Rocatinlimab

Study type

Interventional

Funder types

Industry

Identifiers

NCT05899816
20210158

Details and patient eligibility

About

The primary objectives of this study are to: * estimate vaccine response in rocatinlimab group vs placebo group, assessed using antibody anti-tetanus response at Week 24 * estimate vaccine response in rocatinlimab group vs placebo group, assessed using antibody anti-meningococcal response at Week 24

Enrollment

221 patients

Sex

All

Ages

18 to 54 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

* Age ≥ 18 years to 54 years with a diagnosis of AD according to the American Academy of Dermatology (AAD) Consensus Criteria (2014) present for at least 12 months * History of inadequate response to topical corticosteroids (TCS) of medium, high, or higher potency (with or without topical calcineurin inhibitors) * Subjects with previous systemic treatment for AD are also considered as inadequate responders to topical treatments and are potentially eligible to be included in the study after appropriate washout. * Validated Investigator's Global Assessment for Atopic Dermatitis (vIGA-AD) score ≥ 3

Exclusion criteria

* Treatment with a biologic product within 12 weeks or 5 half-lives, whichever is longer, prior to Day 1 * Treatment with any of the following medications or therapies within 4 weeks or 5 half-lives, whichever is longer, prior to Day 1: * Systemic corticosteroids * Systemic immunosuppressants * Phototherapy * Janus kinase inhibitors * Treatment with any of the following medications or therapies within 1 week, prior to Day 1: * TCS of any potency * Topical calcineurin inhibitors (TCI) * Topical Phosphodiesterase-4 inhibitors (PDE4) * Other topical immunosuppressive agents * Combination topical agents containing a corticosteroid or calcineurin inhibiting component, PDE4 inhibitors, or other topical immunosuppressive agents * Treatment with live virus including live attenuated vaccination 12 weeks prior to day 1 pre-randomization. * Treatment with any meningococcal vaccine within 1 year prior to screening, or treatment with any tetanus-, diphtheria-, or pertussis containing vaccine within 5 years prior to screening

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

221 participants in 2 patient groups, including a placebo group

Rocatinlimab
Experimental group
Description:
Rocatinlimab every 4 weeks (Q4W) for 24 weeks with a loading dose at Week 2.
Treatment:
Drug: Rocatinlimab
Placebo
Placebo Comparator group
Description:
Placebo every 4 weeks (Q4W) for 24 weeks with a loading dose at Week 2.
Treatment:
Drug: Placebo

Trial contacts and locations

86

Loading...

Central trial contact

Amgen Call Center

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems